Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Elekta Limited — Predicate Candidate Screening

8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

100 daysmedian FDA review time

125 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K210500	Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD	Elekta Limited	2021-06-11	109	8
K192482	Elekta Unity	Elekta Limited	2019-12-05	86	2
K192242	Synergy Platform, Synergy, Infinity, VersaHD	Elekta Limited	2019-11-22	95	0
K182076	Elekta Unity	Elekta Limited	2018-12-04	125	2
K153011	iViewDose R1.0	Elekta Limited	2015-12-11	58	0
K131965	XVI R5.0	Elekta Limited	2013-09-25	90	0
K112613	INTEGRITY(TM)	Elekta Limited	2011-12-16	100	2
K111676	APEX	Elekta Limited	2011-09-30	107	1

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda